Reinforced medical tubing

ABSTRACT

A molded spiral reinforced tubing suitable for use in an implantable medical device includes a molded inner layer comprised of an elastomeric material. The molded inner layer includes an inner surface having an inner diameter that defines a lumen and further includes an outer surface having an outer diameter. The outer surface includes one or more recessed pathways formed therein. A continuous reinforcement element is provided within each of the one or more recessed pathways. A molded outer layer comprised of an elastomeric material includes an inner surface having an inner diameter and an outer surface having an outer diameter. The inner surface of the outer layer substantially conforms with the reinforcement element and the outer surface of the inner layer.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of provisional application Ser. No.61/038,206, filed Mar. 20, 2008, entitled “REINFORCED MEDICAL TUBING ANDMETHOD TO MANUFACTURE,” which is incorporated by reference in itsentirety. This application is related to co-pending application Ser. No.______, filed on even date herewith, entitled “Method for ManufacturingReinforced Medical Tubing.”

TECHNICAL FIELD

The present invention relates to medical devices. In particular, thepresent invention relates to a reinforced tubing suitable for use inmedical devices.

BACKGROUND

In certain implantable devices, flexible silicone tubing is used toprovide a fluid conduit between and connect device components. One suchimplantable device is a multi-component inflatable penile prosthesis(IPP). In the early 1980's, spiral reinforcement was incorporated insilicone tubing for IPP to provide kink-resistance. Historically, spiralreinforced silicone tubing is fabricated by first extruding and curingan inner layer of silicone elastomer over a core material, wrapping theinner layer of silicone with spiral reinforcement, extruding and curingan outer layer of silicone elastomer over the spiral reinforced innerlayer, cutting the tubing and core material to desired lengths, andseparating the tubing from the core material.

SUMMARY

The present invention relates to a molded spiral reinforced tubingsuitable for use in an implantable medical device. In one embodiment, amolded inner layer comprised of an elastomeric material includes aninner surface having an inner diameter that defines a lumen and furtherincludes an outer surface having an outer diameter. The outer surfaceincludes one or more recessed pathways formed therein. A continuousreinforcement element is provided within each of the one or morerecessed pathways. A molded outer layer comprised of an elastomericmaterial includes an inner surface having an inner diameter and an outersurface having an outer diameter. The inner surface of the outer layersubstantially conforms with the reinforcement element and the outersurface of the inner layer.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of a molded spiral reinforced tubingaccording to embodiments of the present invention.

FIG. 2 is a cross-sectional view of the molded spiral reinforced tubingshown in FIG. 1.

FIG. 3 is a cross-sectional view of a core and inner layer of the moldedspiral reinforced tubing according to the present invention.

FIG. 3 a is an enlarged cross-sectional view of the core and inner layershown in FIG. 3.

FIG. 4 is a plan view of the core and inner layer of the molded spiralreinforced tubing with a reinforcement member according to the presentinvention.

FIG. 4 a is an enlarged plan view of the core and inner layer with thereinforcement member shown in FIG. 4.

FIG. 5 is a cross-sectional view of the core and inner layer with anouter layer molded over the inner layer and the reinforcement memberaccording to the present invention.

FIG. 5 a is an enlarged cross-sectional view of the outer layer moldedover the inner layer and the reinforcement member shown in FIG. 5.

FIG. 6 is an isometric view of a transfer mold for molding inner andouter layers of a spiral reinforced tubing according to the presentinvention.

FIG. 7 is an isometric view of a transfer mold in an open arrangementshowing the mold cavity halves and a molded shot with inner and outertubing layers.

FIGS. 7 a and 7 b are enlarged plan views of portions of the mold cavityhalves shown in FIG. 7.

FIG. 8 is a cross-sectional view of the molded shot with inner and outertubing layers shown in FIG. 7.

FIGS. 8 a and 8 b are enlarged cross-sectional views of portions of themolded shot shown in FIG. 8.

FIG. 9 is an isometric view of a molded inner layer on the mold core,with multiple centering projections emanating from the outer surface ofthe inner molded layer according to embodiments of the presentinvention.

FIG. 9 a is a cross-sectional view of the molded inner layer on the moldcore shown in FIG. 9.

FIG. 10 is an isometric view of a molded inner layer and reinforcementon a mold core, with a centering sleeve installed over the outer surfaceof the inner molded layer according to embodiments of the presentinvention.

FIG. 11 is an isometric view of molded spiral reinforced tubing with thecentering sleeve on the mold core after molding the outer layer.

FIG. 12 is an isometric view of a transfer mold for molding inner andouter layers of a molded spiral reinforced tubing, depicting axialorientation of the centering sleeve over inner layer prior to molding.

FIG. 13 is an isometric view of a transfer mold for molding inner andouter layers of a molded spiral reinforced tubing, depicting axialorientation of the centering sleeve after molding.

While the invention is amenable to various modifications and alternativeforms, specific embodiments have been shown by way of example in thedrawings and are described in detail below. The intention, however, isnot to limit the invention to the particular embodiments described. Onthe contrary, the invention is intended to cover all modifications,equivalents, and alternatives falling within the scope of the inventionas defined by the appended claims.

DETAILED DESCRIPTION

FIG. 1 depicts a reinforced tubing 1 according to embodiments of thepresent invention. FIG. 2 depicts a sectional view of the molded spiralreinforced tubing 1, and FIG. 2 a is an enlarged view of a segment fromFIG. 2 depicting a single spiral reinforcement member 6, an inner moldedlayer 7, and an outer molded layer 8. The tubing 1 includes a continuouslumen 2 and an outer surface 3 between tubing ends 4 and 5. As will bedescribed in more detail herein, the tubing 1 is molded and includes aspiral reinforcement. It has utility in a variety of applications whereflexible fluid conduit with spiral reinforcement improves performancecharacteristics by enhancing resistance to deformation from internal orexternal forces. In some applications, the reinforced tubing 1 may beused in medical devices, since the construction conforms with variationsin the patient's anatomy. One example use for tubing 1 in a medicaldevice is as a fluid conduit between components in the medical device.Examples of medical devices that might utilize reinforced tubing 1 as afluid conduit between components are inflatable penile prostheses,inflatable mammary prostheses, inflatable urinary or fecal incontinencedevices, inflatable tissue expanders, and devices utilizing implantableinjection ports.

FIGS. 3-5 illustrate steps in the formation of the spiral reinforcedtubing 1 illustrated in FIGS. 1 and 2. FIG. 3 is a sectional view of acore 110 and the inner layer 7 of a molded spiral reinforced tubing 1.FIG. 3 a is an enlarged view of the portion circled in FIG. 3 depictingthe inner molded layer 7 including the lumen 2 (defined by the diameterof the core 110) and an outer surface 9. The outer surface 9 has a majordiameter 14 and includes a recessed pathway 10 for receiving thecontinuous spiral reinforcement member 6 (not shown in FIGS. 3 and 3 a).The pathway 10 includes arc 11 at its base (i.e., the portion of thepathway most proximate to the lumen 2). Surfaces 12 and 13 connect thearc 11 to the outer surface 9. A transition arc 15 may extend betweenthe surface 12 and the outer surface 9, and a transition arc 16 mayextend between the surface 13 and the outer surface 9. In someembodiments, the radius of the arc 11 is sized between about 2% andabout 40% smaller than the radius of the reinforcement member 6, toretain the reinforcement member 6 in the pathway 10 between the surfaces12 and 13. More preferably, the radius of the arc 11 is sized betweenabout 10% and about 20% smaller than the radius of the reinforcementmember 6. The depth of the pathway 10 (extending from the outer surface9 to the bottom of the arc 11) is preferably equal to the diameter ofthe reinforcement member 6.

FIG. 4 depicts the core 110 and the inner layer 7 of the spiralreinforced tubing 1 with the reinforcement member 6 secured to the core110. FIG. 4 a is an enlarged view of the portion circled in FIG. 4depicting the inner molded layer 7 and the reinforcement member 6. Thecore 110 includes crossholes 111 and 112 formed proximate the ends ofthe core 110. The reinforcement member 6 is spirally wound and depositedinto the recessed pathway 10. The ends of the reinforcement member 6 areinserted through the crossholes 111 and 112 of the core 110. The ends ofthe reinforcement member 6 are secured to the core 110 by mechanicalmeans such as a knot, swedging, heading, or a retention cuff, or thereinforcement member 6 may be tucked between the core 110 and the innerlayer 7. If the reinforcement member 6 is metallic in composition,swedging or heading may be accomplished mechanically. If thereinforcement member 6 is a thermoplastic composition, swedging orheading may be accomplished thermally. The core 110 may also haveadditional crossholes 113 and 114 to facilitate securement of thereinforcement member 6 to the core 110. The reinforcement member 6 issecured to the core 110 by first routing the reinforcement member 6through the crosshole 111, then through the crosshole 113, thendepositing the reinforcement into the recessed pathway 10, then routingthe reinforcement through the crosshole 112, and finally through thecrosshole 114. The crossholes 111-114 may penetrate the core 110 in thesame or different radial orientations or may be angled so that thecrosshole entry and exit may be at different elevations along the axisof the core 110 to ease installation of the reinforcement member 6. Thecrossholes 111-114 may be tapered to provide a larger opening or entrytarget to introduce the reinforcement member 6 and a smaller exit toretain the reinforcement member 6. The crossholes 111-114 may beelectro-discharge machined (EDM) in the core 110, wherein the shape ofeach crosshole 111-114 is not limited to a uniform configuration asmight be the case with twist drilling.

In some embodiments, the reinforcement member 6 has a diameter at least0.002 inch smaller than the diameters of the crossholes 111 and 112. Inone actual implementation, a 0.013-inch diameter Nylon 6 monofilamentwas utilized with a single 0.015-inch diameter crosshole on both ends ofcore 110.

The reinforcement member 6 forms a sharp bend as it transitions from thecrosshole entry to overlying the circumference of the core 110 thatprovides a means to retain the reinforcement member 6 in the crosshole.Excess portions of the reinforcement member 6 may be trimmed flush withthe exit side of the crossholes 111, 112.

FIG. 5 depicts a sectional view of the core 110 with the outer tubinglayer 8 molded over the inner tubing layer 7 and the reinforcementmember 6. FIG. 5 a is an enlarged view of the portion circled from FIG.5 depicting the outer molded layer 8 over the inner molded layer 7 andthe reinforcement member 6. The outer molded layer 8 has an outersurface 3 and an inner surface 17. The inner surface 17 is conformalwith the reinforcement member 6 and the outer surface 9 of the innermolded layer 7. In some embodiments, the outer molded layer 8 ischemically and mechanically bonded to inner molded layer 7, but not tothe reinforcement member 6. Bonding of the molded layers 7 and 8mechanically retains the reinforcement member 6 between the recessedpathway 10 of the inner layer 7 and the inner surface 17 of the outerlayer 8. Materials selected for the outer layer 8 and the reinforcementmember 6 prevent bonding of the outer layer 8 to the reinforcementmember 6. If necessary, the reinforcement member 6 should be coated toprevent adhesion of the molded outer layer 8 to the reinforcement member6. Additionally, the reinforcement member 6 may be coated to reduce thesurface tension between the molded layers 7 and 8. The reinforcementmember 6 should move freely in the recessed pathway 10 when the tubingis flexed, to prevent localized stresses that will reduce fatigue life.

Components of the spiral reinforced tubing 1 may be molded from athermoplastic elastomer (e.g., polyurethane or polyvinyl chloride(PVC)), a thermoset elastomer (e.g., silicone or ethylene propylenediene monomer (EPDM)), or a combination of thermoplastic and thermosetelastomers. In certain implantable medical devices, such as implantablepenile prostheses (IPP), silicone elastomer may be favored for itsbiocompatibility and low modulus. In these embodiments, the inner layer7 is molded from a gum or high-consistency elastomer such as Nusil MED4755, a platinum cured two-part elastomer. Two-part platinum elastomershave one part containing a catalyst that is mixed with the another partcontaining a crosslinker. Platinum cured two-part liquid injectionmolding (LIM) elastomer such as Nusil MED 4850 may also be used for theinner layer. High-consistency elastomers have good tear resistance,making them particularly suitable for the inner layer 7. The two partsof high consistency silicone elastomer are usually combined on atwo-roll mill and molded using either compression or transfer moldingmethods. Alternatively, the inner layer 7 may be molded with one-parthigh-consistency elastomer, such as peroxide cured silicone elastomer,that may be compression or transfer molded.

The outer layer 8 may be molded from a gum or high-consistency elastomersuch as Nusil MED 4755 because it has a high tear strength. The surfacetension between the core 110 and the inner tubing layer 7 is configuredto allow removal of the core 110 after molding, but also to minimizemovement of the inner layer 7 on core 110 during overmolding of theouter layer 8. The selected overmolding parameters, such as moldtemperature and transfer speed, optimize the elastomer flow over thereinforcement member 6 and inner layer 7.

The outer layer 8 may also be dispersion coated by dipping or spraying adispersion grade elastomer. Dispersion grade elastomers can beformulated from peroxide, platinum or acetoxy cure silicone elastomerswith a range of solids content using chemical solvents such as xylene,trichloroethane, naptha, hexane and toluene. Two part elastomers may beconverted to dispersions prior to or after combining the two parts.Molding by dispersion coating is considerably slower than molding withgum or LIM elastomers using matched metal molds. The desired thicknessof the outer layer 8 may be achieved with multiple dispersion coatings.Subsequent to volatilizing the dispersion solvent, the siliconeelastomer is vulcanized. Acetoxy cured elastomers may also be used toprovide improved abrasion resistance.

The reinforcement member 6 may be comprised of a metallic or polymericmaterial. Examples of metallic reinforcement are AISI 316L, a low carbonsteel, or MP35N, a chromium, nickel, molybdenum and cobalt alloy.Metallic reinforcement has significantly higher tensile modulus thanplastic reinforcement and can sustain permanent deformation if deformedbeyond its elastic limit. The higher modulus metal reinforcement hasless fatigue resistance than lower modulus plastic reinforcement. Metalreinforcements may be formed using spring winding equipment prior toplacement on the inner layer 7.

Examples of polymeric materials suitable for reinforcement member 6 arenylon, polyester or polypropylene. Plastic reinforcement may be wounddirectly onto the tubing inner layer 7. For certain long-term medicalapplications, such as IPP, plastic reinforcement may better suited thanmetal, because it is less susceptible to permanent deformation, moreresistant to fatigue and provides a more compliant tubing. In someembodiments, polyamide, commonly referred to as nylon, is favored forthe reinforcement member 6 due its physical properties,biocompatibility, and because it is less likely to bond with the innerlayer 7 during vulcanization.

FIG. 6 depicts a family transfer mold 101 with cavity plates 102 and 103in the closed mode. A sprue 104 is depicted in the center of the cavityplate 102. The family transfer mold 101 depicted in FIG. 6 is formolding a short length of molded spiral reinforced tubing 1 fordeveloping test samples and prototypes. It will be appreciated that thecavity plates 102 and 103 can be sized to mold tubing 1 having a desiredlength. A rotary cavity shut off valve 123 in the cavity plate 102allows for molding either the inner or outer layers separately orsimultaneously. In actual implementation, production molds would likelybe multi-cavity versions of either the inner layer 7 or the outer layer8, since the inner layer 7 and the outer layer 8 may be molded fromdifferent elastomers or require different molding parameters such astransfer pressure, transfer speed, mold temperature and vulcanization orcuring cycle times.

FIG. 7 depicts an isometric view of an opened family transfer mold 101with the cavity plates 102 and 103 separated along their longitudinalaxis for molding the inner layer 7 and the outer tubing layer 8. Thecavity plate 102 includes a sprue 104 and a runner 105 for transferringelastomer to ring gate halves 106 and 108 in the cavity plate 102 andthe opposing ring gate halves 107 and 109 located in the cavity plate103. Ring gating from a single end of the tubing to introduce elastomerinto the mold cavities substantially eliminates the potential for knitlines. Ring gating from a single end also minimizes the potential forbending of the mold core 110 that forms the lumen 2. FIG. 7 also depictsan inner layer cavity half 115 and an outer layer cavity half 117 in thecavity plate 103 and an inner layer cavity half 116 and an outer cavityhalf 118 in the cavity plate 102.

FIGS. 7 a and 7 b are enlarged plan views of the circled portions on thecavity plate 103 and the cavity plate 102, respectively, in FIG. 7. FIG.7 a is a plan view of the reinforcement securement surround half 119located between the ring gate half 109 and the outer layer cavity half117 in the cavity plate 103. FIG. 7 b is a plan view of thereinforcement securement surround half 120 located between the ring gatehalf 108 and the outer layer cavity half 118 in the cavity plate 102. Areinforcement securement surround half 121 adjacent the outer layercavity half 117 in cavity plate 103 and a reinforcement securementsurround half 122 adjacent the outer layer cavity half 118 in cavityplate 102 are shown in FIG. 7. The reinforcement securement surroundsprovide a segment to accommodate the bulk of the reinforcementsecurement means described above. FIG. 7 also shows a molded shotbetween separated cavity plates 102 and 103. The molded shot includesthe inner layer 7 over the core 110, the outer tubing layer 8 over theinner tubing layer 7 and the reinforcement member 6, and a runner 18connecting the cores 110.

The mold cavity plates 102 and 103 may be filled with a thermosetelastomer material using any suitable molding technique, such ascompression, transfer, or LIM molding. With compression molding, theelastomer is placed in the mold cavities 115-118 and the elastomer iscompressed as the mold is closed to fill out the part, replicating themold detail. With transfer molding, the elastomer is placed in atransfer pot, usually a component of the press or mold. Transfer moldingis accomplished by either closing the mold, if using a compressionmolding press, or closing the mold and activating the transfer plungerif using a transfer press. In either case, the elastomer is transferredthrough the sprue 104 in the mold and subsequently through the ring gate106-109 to fill the mold forming the part. The runner 105 may be used toconnect the sprue 104 and the gate 106-109. With LIM molding, multiplecomponents of liquid elastomer are pumped separately to a mixing chamberfrom which they are fed into an injection chamber. The injection moldingpress closes the mold cavity plates 102 and 103 and subsequently injectsthe combined multi-component elastomer into the mold cavities 115-118,filling out the part. For thermoset elastomers, the parts may becompression, transfer or injection molded by introducing uncuredelastomer into the mold cavities 115-118, thermally curing the elastomerfor a specific time, opening the mold, and removing the part along withthe sprue 104 and runner 105. For any thermoplastic elastomer, the partsmay be injection molded by introducing molten elastomer into the moldcavities 115-118, thermally cooling the elastomer for a specific time,opening the mold, and removing the part along with the sprue 104 andrunner 105.

FIG. 8 is a cross-sectional view of a single molded shot including themolded inner layer 7 on the core 110, the outer layer 8 molded over theinner layer 7 and the reinforcement member 6, and the runner 18connecting cores 110. FIG. 8 a is an enlarged cross-sectional view ofthe portion circled of the inner layer 7 on the core 110 in FIG. 8depicting the ring gate 19. FIG. 8 b is an enlarged cross-sectional viewof the portion circled of the outer layer 8 on the core 110 in FIG. 8,depicting the ring gate 20 and the reinforcement securement surround 21.

While the present invention has been described with regard to areinforced tubing 1 including a single spiral reinforcement member 6, itwill be appreciated that variations on this design are contemplated. Forexample, in an alternative embodiment, the tubing 1 may be configured toaccommodate a plurality of continuous spiral reinforcement members 6.Multiple spiral reinforcement members 6 may have advantages in certainapplications and may be accomplished by providing detail for multiplereinforcement pathways 10 in the inner layer cavity halves 115 and 116,additional crossholes in the core 110, multiple recessed pathways 10 inthe inner layer 7 and multiple reinforcement members 6 in the moldedspiral reinforced tubing 1. Multiple reinforcement members 6 may beused, for example, to reduce the reinforcement angle with respect to thelongitudinal axis of the tubing 1. Multiple reinforcement members 6provide a larger reinforcement angle with respect to the tubing axis andwill facilitate greater radial expansion of the lumen 2 for applicationsinvolving insertion of a connector or tubing insert.

In alternative embodiments, the reinforced tubing 1 is assembled withelements that provide additional functional components in the tubing 1.For example, in embodiments including multiple recessed pathways 10, acolor coding member may be formed in one of the recessed pathways 10 tocolor code the tubing 1 for identification for particular applications.As another example, one or more of the multiple recessed pathways 10 mayhave one or more electrically conductive paths formed therein tocommunicate electrical signals between components connected by thetubing 1. One or more of the multiple recessed pathways 10 may alsoinclude a fiber optic element to facilitate optical communication acrossthe tubing 1. Furthermore, one or more of the multiple recessed pathways10 may have a sensing element formed therein to sense physiologicalcharacteristics (e.g., oxygen or pH levels) around the tubing 1.

FIG. 9 depicts inner layer 7 on the core 110 with multiple centeringprojections 125 emanating from the outer surface 14 of the inner layer7, according to an alternative embodiment of the present invention. FIG.9 a is an enlarged view of a cross-section of the inner layer 7 and thecore 110 shown in FIG. 9 depicting multiple centering projections 125emanating from the major diameter 14 of the inner layer 7. Theembodiment shown in FIGS. 9 and 9 a is configured to center the innerlayer 7 with respect to the outer layer mold cavities 117 and 118 duringmolding of the outer layer 8. In particular, the centering projections125 are configured to contact the outer layer mold cavity halves 117 and118, during molding of the outer molded layer 8, to facilitate centeringof inner molded tubing layer 7 within outer molded tubing layer 8. Insome embodiments, the centering projections 125 are positioned at aminimum of 120° apart radially, and a suitable distance apart axially,to maintain centering with respect to the mold cavity halves 117 and118.

The centering projections 125 is just one example mechanism that may beused to center the inner layer 7 with respect to the outer layer moldcavities 117 and 118 during overmolding. For example, FIG. 10 depictsthe inner layer 7 and the reinforcement member 6 on the core 110 and acentering sleeve 124 positioned over the outer surface 14 of the innerlayer 7 and the reinforcement member 6, according to another embodimentof the present invention. The centering sleeve 124 is disposed aroundthe outer surface 14 of the inner layer 7 and centers the inner layer 7and the reinforcement member 6 within outer molded tubing layer 8,during molding of the outer layer 8. In some embodiments, the diameterof the bore of centering sleeve 124 is sized 0.001 to 0.002 inch greaterthan the diameter of the outer surface 14 of the inner layer 7 and theouter radius of the centering sleeve 124 is sized 0.001 to 0.002 inchsmaller than the radii of the outer layer cavity halves 117 and 118. Thecentering sleeve 124 is placed over the inner layer 7 and thereinforcement member 6 and axially located proximal to outer layer ringgate halves 108 and 109. As elastomer is introduced into the mold, itadvances the centering sleeve 124 axially between inner molded tubinglayer 7 and cavity halves 117 and 118 until the elastomer flow iscomplete and the centering sleeve 124 is distal to the ring gate 108,109. The centering sleeve 124 can be fabricated from a heat resistantplastic such as polysulfone or metal such as aluminum or stainlesssteel. FIG. 11 depicts molded spiral reinforced tubing with the outerlayer 8 and the centering sleeve 124 on the mold core 110 after moldingthe outer layer 8.

FIG. 12 is an isometric view of a family transfer mold for molding theinner layer 7 and the outer layer 8, prior to molding the device shownin FIGS. 10 and 11. The cavity plates 102 and 103 are separated alongtheir longitudinal axis. The centering sleeve 124 is located proximal tothe ring gate half 108 of the cavity plate 102 and the ring gate half109 of the cavity plate 103 prior to molding. The centering sleeve 124is radially positioned over the inner layer 7 and the reinforcementmember 6 on the core 110. FIG. 13 is an isometric view of a familytransfer mold after molding the inner layer 7 on the core 110 and theouter layer 8 over the inner layer 7 and the reinforcement member 6. Asis shown, the centering sleeve 124 travels to the end distal to the ringgate 108, 109 during molding of the outer layer 8.

Molded tubing provides design opportunity because the bore and majordiameter need not have a continuous profile. Molding multiple layertubing provides additional design freedom especially when reinforcementis incorporated in the tubing. For example, the tubing 1 of the presentinvention has a non-continuous outer surface 14 on the inner layer 7that includes a recessed pathway 10 for accommodating a spiralreinforcement member 6. The recessed pathway 10 eliminates the need totension the reinforcement member 6 to stabilize it during subsequentmanufacturing operations, which also provides design opportunity tofabricate tubing 1 with a continuous lumen 2. A reinforcement member 6that is not tensioned is less likely to cause localized stress thatcould initiate fatigue failure than a tensioned reinforcement. Inaddition, the greatest elongation during bending or flexing of the innerlayer of the tubing 1 is directed to the thinnest cross-section at thebottom of the recessed pathway 10. The compressive and tensile stressesfrom flex of the tubing 1 are minimized by reducing the thickness.Spiral reinforcement member 6 causes the greatest abrasive activity atthe base of the recessed pathway during flex of the tubing 1. However,the reduction or elimination of tension on the reinforcement member 6 asis done in the tubing 1 according to the present invention cansignificantly reduce this abrasive activity. That is, the tubing 1 isprovided with the recessed pathway 10 on the inner layer 7, facilitatingspiral reinforcement with minimal or no tension, so that compressiveforces caused by the reinforcement member 6 on the adjacent inner layer7 during flex of tubing 1 are reduced for greater fatigue resistance.

One or more of the following advantages may be provided in certainimplementations. First, molded spiral reinforced tubing can be providedthat is simple to manufacture. Second, molded spiral reinforced tubingcan be provided that can be manufactured more consistently than extrudedspiral reinforced tubing. Third, molded tubing provides greater designfreedom over extruded tubing because the tubing profile need not becontinuous and enables incorporation of features for ease of manufactureor improved performance. Fourth, molded spiral reinforced tubing can beprovided with a constant lumen without undulations from tensionedreinforcement. Fifth, molded spiral reinforced tubing can be providedwith greater fatigue resistance than extruded spiral reinforced tubing.

A significant advantage in molded silicone tubing over extruded siliconetubing is that molded tubing is compressed and densified duringvulcanization or curing. Extruding tubing is compressed as it is forcedthrough an extrusion die but is not densified during vulcanization.Physical properties are enhanced as the interface between the elastomerand reinforcing filler improves and mechanical densification that occursduring closed molding improves that interface.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. For example, while the embodiments described above refer toparticular features, the scope of this invention also includesembodiments having different combinations of features and embodimentsthat do not include all of the described features. Accordingly, thescope of the present invention is intended to embrace all suchalternatives, modifications, and variations as fall within the scope ofthe claims, together with all equivalents thereof.

1. A tubing for connecting components in medical devices, the tubingcomprising: a molded inner layer comprised of an elastomeric material,wherein the inner layer includes an inner surface having an innerdiameter that defines a lumen and further includes an outer surfacehaving an outer diameter, and wherein the outer surface includes one ormore recessed pathways formed therein; a continuous reinforcementelement within at least one of the one or more recessed pathways; and amolded outer layer comprised of an elastomeric material, wherein theouter layer includes an inner surface having an inner diameter and anouter surface having an outer diameter, and wherein the inner surface ofthe outer layer substantially conforms with the reinforcement elementand the outer surface of the inner layer and is secured to the outersurface of the inner layer.
 2. The tubing of claim 1, wherein the outerlayer is chemically and/or mechanically secured to the inner layer. 3.The tubing of claim 1, wherein the outer layer is not chemically ormechanically secured to the reinforcement element.
 4. The tubing ofclaim 1, wherein the reinforcement element comprises a coating to reducesurface tension between the reinforcement element and the inner andouter layers.
 5. The tubing of claim 1, wherein at least one of theinner layer and the outer layer comprises a thermoplastic elastomer. 6.The tubing of claim 5, wherein the thermoplastic elastomer comprises amaterial selected from the group consisting of polyvinyl chloride (PVC)and polyurethane.
 7. The tubing of claim 1, wherein at least one of theinner layer and the outer layer comprises a thermoset elastomer.
 8. Thetubing of claim 7, wherein the thermoset elastomer comprises a materialselected from the group consisting of ethylene propylene diene monomer(EPDM) and silicone.
 9. The tubing of claim 8, wherein the outer layeris coated with an acetoxy cured silicone to enhance abrasion resistance.10. A tubing of claim 9, wherein the acetoxy cured silicone is appliedas a dispersion.
 11. The tubing of claim 1, wherein each recessedpathway includes an arc having a radius at its base.
 12. The tubing ofclaim 11, wherein the radius of the arc is between about 2% and about40% smaller than a radius of the reinforcement element.
 13. The tubingof claim 12, wherein the radius of the arc is between about 10% andabout 20% smaller than a radius of the reinforcement element.
 14. Thetubing of claim 1, wherein each recessed pathway includes transitionarcs between the outer surface of the inner layer and the recessedpathway.
 15. The tubing of claim 1, wherein a depth of the one or morerecessed pathway is substantially equal to a diameter of thereinforcement element.
 16. The tubing of claim 1, wherein thereinforcement element is comprised of a metallic material.
 17. Thetubing of claim 16, wherein the metallic material is selected from thegroup consisting of carbon steel, non-carbon steel, stainless steel, andMP35N.
 18. The tubing of claim 1, wherein the reinforcement element iscomprised of a polymeric material.
 19. The tubing of claim 18, whereinthe polymeric material is selected from the group consisting ofpolypropylene and polyamide.
 20. The tubing of claim 1, wherein theouter surface of the inner layer includes a plurality of projectionsconfigured to contact an outer layer mold during molding of the outerlayer to facilitate centering of the inner layer with respect to theouter layer.
 21. The tubing of claim 1, and further comprising at leastone of a sensor, a fiber optic cable, and an electrical conductor withinat least one of the one or more recessed pathways.
 22. The tubing ofclaim 1, wherein the medical device is selected from the groupconsisting of an inflatable penile prosthesis, an inflatable urinaryincontinence device, and inflatable fecal incontinence device, aninflatable mammary prosthesis, an inflatable tissue expander, and amedical device with a remote injection port.